Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 MI 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 MI 2 DOMAIN Domain Abbreviation Char MI Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 MI 3 USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req
SDTMIG 3.3 MI 4 MISEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 MI 5 MIGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. Perm
SDTMIG 3.3 MI 6 MIREFID Reference ID Char Identifier Internal or external specimen identifier. Example: Specimen barcode number. Perm
SDTMIG 3.3 MI 7 MISPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the MI Findings page. Perm
SDTMIG 3.3 MI 8 MITESTCD Microscopic Examination Short Name Char (MITSCD) Topic Short name of the measurement, test, or examination described in MITEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MITESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MITESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "HER2", "BRCA1","TTF1". Req
SDTMIG 3.3 MI 9 MITEST Microscopic Examination Name Char (MITS) Synonym Qualifier Verbatim name of the test or examination used to obtain the measurement or finding. The value in MITEST cannot be longer than 40 characters. Examples: "Human Epidermal Growth Factor Receptor 2", "Breast Cancer Susceptibility Gene 1", "Thyroid Transcription Factor 1". Req
SDTMIG 3.3 MI 10 MITSTDTL Microscopic Examination Detail Char (MIFTSDTL) Record Qualifier Further description of the test performed in producing the MI result. This would be used to represent specific attributes, such as intensity score or percentage of cells displaying presence of the biomarker or compound. Perm
SDTMIG 3.3 MI 11 MICAT Category for Microscopic Finding Char Grouping Qualifier Used to define a category of related records. Perm
SDTMIG 3.3 MI 12 MISCAT Subcategory for Microscopic Finding Char Grouping Qualifier Used to define a further categorization of MICAT. Perm
SDTMIG 3.3 MI 13 MIORRES Result or Finding in Original Units Char Result Qualifier Result of the histopathology measurement or finding as originally received or collected. Exp
SDTMIG 3.3 MI 14 MIORRESU Original Units Char (UNIT) Variable Qualifier Original unit for MIORRES. Perm
SDTMIG 3.3 MI 15 MISTRESC Character Result/Finding in Std Format Char Result Qualifier Contains the result value for all findings, copied or derived from MIORRES in a standard format or standard units. MISTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in MISTRESN. Exp
SDTMIG 3.3 MI 16 MISTRESN Numeric Result/Finding in Standard Units Num Result Qualifier Used for continuous or numeric results or findings in standard format; copied in numeric format from MISTRESC. MISTRESN should store all numeric test results or findings. Perm
SDTMIG 3.3 MI 17 MISTRESU Standard Units Char (UNIT) Variable Qualifier Standardized unit used for MISTRESC and MISTRESN. Perm
SDTMIG 3.3 MI 18 MIRESCAT Result Category Char Variable Qualifier Used to categorize the result of a finding. Examples: "MALIGNANT" or "BENIGN" for tumor findings. Perm
SDTMIG 3.3 MI 19 MISTAT Completion Status Char (ND) Record Qualifier Used to indicate examination not done or result is missing. Should be null if a result exists in MIORRES or have a value of "NOT DONE" when MIORRES is null. Perm
SDTMIG 3.3 MI 20 MIREASND Reason Not Done Char Record Qualifier Reason not done. Used in conjunction with MISTAT when value is NOT DONE. Examples: "SAMPLE AUTOLYZED", "SPECIMEN LOST". Perm
SDTMIG 3.3 MI 21 MINAM Laboratory/Vendor Name Char Record Qualifier Name or identifier of the vendor (e.g., laboratory) that provided the test results. Perm
SDTMIG 3.3 MI 22 MISPEC Specimen Material Type Char (SPECTYPE) Record Qualifier Subject of the observation. Defines the type of specimen used for a measurement. Examples: "TISSUE", "BLOOD", "BONE MARROW". Req
SDTMIG 3.3 MI 23 MISPCCND Specimen Condition Char (SPECCOND) Record Qualifier Free or standardized text describing the condition of the specimen. Example: "AUTOLYZED". Exp
SDTMIG 3.3 MI 24 MILOC Specimen Collection Location Char (LOC) Record Qualifier Location relevant to the collection of the specimen. Examples: "LUNG", "KNEE JOINT", "ARM", "THIGH". Perm
SDTMIG 3.3 MI 25 MILAT Specimen Laterality within Subject Char (LAT) Variable Qualifier Qualifier for laterality of the location of the specimen in MILOC. Examples: "LEFT", "RIGHT", "BILATERAL". Perm
SDTMIG 3.3 MI 26 MIDIR Specimen Directionality within Subject Char (DIR) Variable Qualifier Qualifier for directionality of the location of the specimen in MILOC. Examples: "DORSAL", "PROXIMAL". Perm
SDTMIG 3.3 MI 27 MIMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. This could include the technique or type of staining used for the slides. Examples: "IHC", "Crystal Violet", "Safranin", "Trypan Blue", or "Propidium Iodide". Perm
SDTMIG 3.3 MI 28 MILOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. Perm
SDTMIG 3.3 MI 29 MIBLFL Baseline Flag Char (NY) Record Qualifier Indicator used to identify a baseline value. The value should be "Y" or null. Note that MIBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset. Exp
SDTMIG 3.3 MI 30 MIEVAL Evaluator Char (EVAL) Record Qualifier Role of the person who provided the evaluation. Example: "PATHOLOGIST", "PEER REVIEW", "SPONSOR PATHOLOGIST". Perm
SDTMIG 3.3 MI 31 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 MI 32 VISIT Visit Name Char Timing 1. Protocol-defined description of clinical encounter. 2. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 MI 33 VISITDY Planned Study Day of Visit Num Timing Planned study day of the visit based upon RFSTDTC in Demographics. Perm
SDTMIG 3.3 MI 34 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the element in which the assessment was made. Perm
SDTMIG 3.3 MI 35 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the date/time at which the specimen was collected. Perm
SDTMIG 3.3 MI 36 MIDTC Date/Time of Specimen Collection Char ISO 8601 Timing Date/time of specimen collection, in ISO 8601 format. Exp
SDTMIG 3.3 MI 37 MIDY Study Day of Specimen Collection Num Timing Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. Perm